- Device
- IntellaTip MiFi Filter Module and IntellaTip MiFi Reference Cable
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S130
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-04-08
- Decision code
- APPR
- Date received
- 2021-03-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Boston Scientific Corporation, 4100 Hamline Avenue North, Saint Paul, Minnesota, for the manufacturing, distribution, and warehousing activities for the IntellaTip MiFi Filter Module and IntellaTip MiFi Reference Cable.